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Pre-marketing approval from the US Food and Drug Administration (FDA) is required for any new material that is to be marketed in the United States for any application that has direct or indirect contact with food.

This requirement applies to new packaging materials, new baking or cooking materials, coatings for beverage cans and other containers that hold drinkable liquids, and inks and adhesives applied to plastic packaging. The Food Contact Notification Program, overseen by the FDA’s Center for Food Science and Nutrition (CFSAN), provides manufacturers of the new materials or manufacturers that use the new materials in their products, with a regulatory pathway and process to notify the FDA of the new use.

The role of FDA’s food contact notification program

The Food Contact Notification (FCN) Program is in place to ensure that manufacturers bringing new products to market that come into contact food do not create a risk to public health by doing so. A migration study is required by the FDA to make certain the analytes that migrate from the material into food products do not increase rates of cancer rate in the population by more than one additional case per 100,000 people. The Agency’s published guidance, titled Guidance to Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations, outlines the migration study and food chemistry calculations that lead to the safety assessment. Analytical techniques for measuring analytes at trace levels include high-performance liquid chromatography (HPLC), liquid chromatography mass spectrometry (LC-MS), gas chromatography with flame-ionization detection (GC-FID), and gas chromatography mass spectrometry (GC-MS).

Establishing methods and measuring the food contact substance (FCS)

Methods for measuring the food contact substance (FCS), as well as any impurities in the food simulant, are established during method development and migration screening activities. The migration study will involve triplicate analysis as well as method validation per guidance which include fortification and recovery experiments using three (3) sets of triplicate samples of the test simulants with each set fortified at a separate level. The fortification levels will be at one-half (1/2), one (1), and two (2) times the measured concentration of the analyte in the food simulant. If the analyte is not detected, the detection limit will be measured.

If the migration results in less than 0.5 ppb of any analyte in the diet, it may be more appropriate for a request for exemption under the threshold of regulation. This request for a letter of no objection may be a more rapid, but non-proprietary, regulatory path. If migration results indicate dietary exposures between 0.5 ppb and 50 ppb, Ames and Chromosomal Aberration studies will need to be performed to support the safety narrative. It is important to note that above 50 ppb in the diet, multi-generational feeding studies on rodents will be required.

FDA review and timeline for FCN filing decisions

The reviewer at the FDA will conduct a phase 1 review, typically within one month after the dossier is submitted to the Agency. Questions will be asked, and the Agency will require a response from the submitter. A final decision must be made on the application within a statutory 120 days, which starts from the original submission date. If the FDA does not provide a specific objection, the notification will become effective on day 120 regardless of whether the submitter receives any actual affirmation. The typical procedure involves delivering a letter to the submitter sometime after the 120-day period ends.

How ÌìÃÀ´«Ã½ can support your premarket submission for food contact substances

Element has broad and deep expertise in the regulations and testing of new food contact substances. Our consultative teams of scientific and regulatory experts can advise and recommend submission strategies, perform necessary analytical testing per the FDA Guidance to Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations, prepare the Food Contact Notification (FCN), hold prenotification consultations with the FDA, and respond to any deficiencies in the dossier. If you have questions, contact one of our experts today.